(105 days)
The NC TREK™ OTW Coronary Dilatation Catheter is indicated for:
- balloon dilatation of the stenotic portion of a coronary artery or . bypass graft stenosis for the purpose of improving myocardial perfusion;
- balloon dilatation of a coronary artery occlusion for the purpose ● of restoring coronary flow in patients with ST-segment elevation myocardial infarctions;
- balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).
The NC TREK OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has two radiopaque markers under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device. The document is a 510(k) summary for a non-AI medical device, specifically the NC TREK™ OTW Coronary Dilatation Catheter, which is a balloon catheter used for coronary artery procedures.
The information provided relates to:
- Device Description: An over-the-wire co-axial design with a balloon at the distal tip for coronary dilation.
- Indications for Use: Balloon dilation of stenotic coronary arteries/bypass grafts, coronary artery occlusions (for ST-segment elevation myocardial infarctions), and balloon dilation of stents after implantation.
- Technological Characteristics: Claims substantial equivalence to predicate devices in product performance, design, and intended use.
- Performance Data:
- Biocompatibility Testing: Included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, complement activation, and pyrogenicity according to ISO 10993-1:2009 and FDA guidance.
- In Vitro Bench Testing: Included catheter preparation, balloon inflation/deflation, catheter shaft fatigue/rupture, distal/proximal adaption tensile, inner member collapse, kink and flexibility, torque, and catheter coating particulate/integrity.
- Conclusion: Stated that the device "met all acceptance criteria and performed similarly to the predicate devices" and that "no new safety or effectiveness issues were raised."
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and an AI/ML-related study as those details are not present in the provided text. The document describes a traditional medical device submission (a PTCA catheter) and its associated non-AI performance testing.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.